Intraosteal ultrasound during surgical implantation

ABSTRACT

IntraOsteal UltraSound (IOUS) is the use of acoustical energyto facilitate “real-time” manipulation and navigation of a device for intraosseous placement of synthetic or biologic implants and to diagnose the condition of the tissue into which the implant is being placed. Representative applications include placement of synthetic or biologic implants, such as bone screws, through vertebral pedicles during spinal fusion surgery. Devices for use in the placement of the implants include a means for creating a lumen or channel into the bone at the desired site in combination with a probe for providing realtime feedback of differences in density of the tissue, typically differences in acoustical impedence between cancellous and cortical bone. The devices will also typically include means for monitoring the feedback such as a screen creating an image for the surgeon as he creates the channel, and/or an audible signal which different tissues are present. The system can also be used for diagnostic applications.

[0001] This applications claims priority to U.S. Provisional PatentApplication No. 60/348,446 filed Oct. 24, 2001.

BACKGROUND OF THE INVENTION

[0002] The present invention is generally in the field of methods anddevices for surgical placement of implants, especially into bone.

[0003] Surgical implantation of devices such as screws, pins, and othermedical implants into bone is frequently the only means to safelyimmobilize the bone. Typically, this is done by passing a probe throughthe cortical bone, the dense, hard bone on the outside of bonystructures, and into the cancellous bone, the soft, compliant spongybone on the inside of the bone.

[0004] As shown in FIG. 1, the relevant structures are the pedicles 12and vertebral body 10. These structures are comprised of two types ofbone: cortical 14 and cancellous 16. Cortical bone is the dense, hardbone covering the illustrated structures. Cancellous bone, commonlyreferred to as “spongy bone” is “soft” and compliant and provides theinner core for these structures.

[0005] Surgeons exploit the difference in these two bone types duringpedicular cannulation. When passing a blunt, narrow “probe” through thepedicle, the instrument tip tends to follow the path of leastresistance, the cancellous bone. The operator continues to direct thisinstrument, usually with x-ray assistance, until it has penetrated50-80% of the anterior/posterior diameter of vertebral body. Successfulcannulation is achieved when an intra-cancellous pilot channel iscreated without a breach of the cortical bone. A breach can injurecritical structures in close proximity, such as spinal cord, nerve root,and vessels. The larger the cancellous inner core and the thicker theouter cortex, the easier the task. This is the case, for example, in thelumbar vertebrae, particularly the L3-S1 pedicles. However, in ascendingthe spine from the lumbar to thoracic and cervical vertebrae, thecomplexity of the task increases substantially. Since pedicularcannulation is essentially a “blind” technique, tactile feedback iscritical to the operator during creation of the pilot channel. When theboundaries of the bone type are large and well defined, as theygenerally are in the lumbar pedicles, the relatively thick cortical walland large core of cancellous bone facilitates intraosteal passage of ablunt tipped probe. The cortical/cancellous boundary is readily detectedas the probe is advanced. In higher vertebrae, i.e., thoracic andcervical, the pedicle dimensions decrease markedly. As the overallcross-sectional diameter of the pedicle decreases, so does the corticalwall thickness. As the operator's tactile sensitivity to thecortical/cancellous boundary decreases, the risk for breach increases,even with adjunctive virtual image guidance.

[0006] A high complication rate associated with pedicle screw placementin lumbar vertebrae is well documented. As previously stated, the riskis even higher in thoracic and cervical spine. Placement of pediclescrews in the certical vertebrae, with the exception of perhaps C2 andC7, is virtually unheard of. Most posterior fixation procedures of thecervical spine, therefore, are through screw fixation in the lateralmasses; not nearly as strong as pedicular fixation.

[0007] Since pedicular fixation in many cases provides for maximumconstruct stability and strength an alternative and improved method andmode of navigation is essential for routine cannulation of these uppervertebral pedicles.

[0008] Currently, there is no simple or reliable method to navigatecannulation of vertebral pedicles in vivo and in real time duringplacement of implants. This is a challenging task even in the hands ofthe most experienced spine surgeon, especially in the upper thoracic andcervical vertebrae. Current modes of virtual guidance are all based on“historical” data and the images upon which the guidance is dependent donot necessarily present the actual anatomic position at any giveninstant in real time an instrument is engaging tissue.

[0009] It is therefore an object of the present invention to providemethods and devices to guide cannulation or other procedures within boneor similar types of materials in the body, which are reliable andrealtime.

SUMMARY OF THE INVENTION

[0010] As defined herein, IntraOsteal UltraSound (IOUS) is the use ofacoustical energy, .e., ultrasound, to facilitate “real-time”manipulation and navigation of a device for intraosseous placement ofsynthetic or biologic implants. Representative applications includeplacement of synthetic or biologic implants, such as bone screws,through vertebral pedicles during spinal fusion surgery. Such implantsare part of a larger “construct” designed to immobilize unstablevertebrae incorporated by it. The purpose of such a construct is topermit bony fusion of those unstable vertebrae that contribute to painor impaired spine function. Devices for use in the placement of theimplants include a means for creating a lumen or channel into the boneat the desired site in combination with a probe for providing realtimefeedback of differences in density of the tissue, typically differencesin density between cancellous and cortical bone. The devices alsotypically includes means for monitoring the feedback such as a screencreating an image for the surgeon as he creates the channel.

[0011] IOUS can also be used for measurement of bone thickness,identification and confirmation of pseudoarthrosis in failed spinalfusions, bone-to-avascular-necrosis interface, guidance of pediclescrews across a vertebral body during anterior spinal deformitycorrective surgery, and search for osteoid osteoma and vascular lesionssuch as aneurismal bone cysts, etc.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012]FIG. 1 is a diagram of a thoracid vertebrate (T6) showing thepedicles, corticle bones, cancellous bone, and bone screw trajectory forspinal fusion.

[0013]FIGS. 2a, 2 b and 2 c are diagrams of a device for use in IOUS,including a computer processor, acoustical generator, monitor,articulating arm, and transducer input ports. FIG. 2a, perspective view;FIG. 2b, side view; FIG. 2c, top view.

[0014]FIG. 3 is a perspective view of a transducer.

[0015]FIG. 4 is a perspective view of input means from the transducer tothe transducer input port.

[0016]FIGS. 5a and 5 b are schematics of the process, wherein thecomputer processor processes the input and output from the acousticalgenerator and transducer in FIG. 5a, to produce an image, shown in FIG.5b.

[0017]FIGS. 6a-d are perspective views of the instruments used in theprocess. FIGS. 6a and 6 b are drill bits of a type currently availablemodified to incorporate transducers that provide feedback to create animage as the drill bit creates a pilot hole. FIGS. 6c and 6 d areperspective views of an instrument that is both a transducer and capableof creating a pilot hole.

DETAILED DESCRIPTION OF THE INVENTION

[0018] An IntraOsteal UltraSound (IOUS) based system is used for theplacement of implants, both initially and/or as the surgeon isoperating, and for detection and characterization of bone to enable thesurgeon to determine the precise location to begin surgery to place theimplant, as well as to determine the condition of the tissues into whichthe implant is to be placed.

[0019] The system includes a device for sensing and alerting via anauditory or visual signal the absence of bone (cortical, cancerous,cartilaginous) i.e., as would be the case of a bony non-union(pseudoarthrosis), fracture, neoplasms, avascular necrosis, vascularlesions, etc. Such abnormalities will have acoustical properties withechogenicity widely disparate from all normal bone types. The IOUSprovides a means to qualitatively recognize or delineate abnormalregions, to insure that any implant being guided and placed is done soin bone of a normal caliber (density, homogeneity, architecture, etc.).The frequency range of bone is such that any quantifiable signal fallingoutside of a particular range will produce an alert signal that isdifferent than that of a signal produced with normal bone. This isimportant when navigating from one bony structure to another bonystructure across a non-,bony interface, i.e., as in joints, especiallywhen implanting facet screws, hip pins, etc.

[0020] Effective deployment of IOUS can be predicated on a multiplenumber of factors or variables that are unique to bone, including:

[0021] 1. Bone mineral density (BMD).

[0022] 2. Histology of bone;

[0023] 3. Bone disease or degeneration

[0024] 4. Water content (blood, bone marrow, etc.).

[0025] 5. Cartilage composition.

[0026] In its totality, bone, in all of its iterations, combinations andarchitecture, has a distinct “signature”. It's echogenicity, modes ofattenuation, scattering coefficients, and other characteristics willalways be quite distinct from other soft tissues of the. The array ofacoustical properties, i.e., frequency, bandwidth, attenuationcharacteristics, amplitude, scatter coefficients, will all be unique foreach type of bone. Effective navigation involves not only delineatingcortical bone from cancellous bone but the integrity of those elementsas well.

[0027] I. Implants

[0028] A number of different types of implants can be placed using thedevices described herein. In the simplest embodiment, the implant is atitanium screw or pin which is implanted into a channel created bychanneling a probe through the cortical bone into the cancellous bonewithin the bone to be immobilized.

[0029] In the preferred embodiment, the bone is a vertebral body andchannels are created within the pedicles of adjacent vetebral bodieswhich are then screwed together. Simply put, this spine construct isanalogous to a splint or cast placed on or around long bone fracturesuntil healing (fusion) occurs. Screws can be removed after the bone hashealed.

[0030] Other implants that can be used include pedicle screws and hippins. Implants may be formed of metal, ceramic, polymer, biologicalmaterials (including bone), and combinations thereof.

[0031] II. Devices That Can Be Used to Image the Area

[0032] Devices include at a minimum a probe for moving within the tissueto be imaged and means for applying and/or receiving ultrasound oracoustic energy, and means for transmitting data to an externalmonitoring means. Optionally, the devices also including means forplacement of the implant, and signaling devices that generate a signalwhen the probe crosses from one type of tissue to another.

[0033] Ultrasound is a form of energy that is quantifiable, reliable,non-ionizing, and relatively inexpensive. The different acousticalproperties of cortical and cancellous bone make it amenable to real timeinterrogation and delineation during instrument manipulation. There aretwo modes by which acoustical energy that is emitted and received invivo could be utilized for reliable guidance:

[0034] 1. Visual (Radar): Though a small transducer mounted on or withina narrow instrument, emission of a predefined acoustical signal, can,upon reflection, be electronically processed to present the disparatesignals, altered by the marked difference in echogenicity of corticaland cancellous bone, into a visual graphic image displaying therelationship of the instrument tip with respect to thecortical/cancellous tissue in both the axial and sagital planes.

[0035] 2. Auditory (Sonar): By a process similar to the above, thealtered signal can be processed such that when a given threshold is met,e.g., when the instrument tip is in direct contact with cortical bone,an audible tone can be generated alerting the operator of an impendingbreach if he were to continue the manipulation at the presenttrajectory.

[0036] 3. Dual Visual/Auditory: By blending the benefits of both, theoperator has constant feedback that would enhance accuracy andefficiency of cannulation.

[0037] III. Methods for Detection and Characterization of Bone

[0038] The ultrasound is used to measure or provide analysis of one ormore factors or variables, including

[0039] 1. Bone mineral density (BMD);

[0040] 2. Histology of bone, i.e., cancellous which is trabecular versuscortical which is lamellar;

[0041] 3. disease such as osteoporosis, calcification, pseudoarthrosisor arthritis;

[0042] 4. water content (blood, bone marrow, etc.);

[0043] 5. cartilage composition;

[0044] 6. lesions, vascular defects, neoplasms, or avascular necrosis.

[0045] This information assists in knowing the integrity (ex. normalBMD, low BMD) of where one is going as well as the location (ex.cortical to cancellous) one is going to.

[0046]FIGS. 2a-2 c represent a system 20 for use as described herein.The system 20 includes a computer processing unit (“CPU”) 22,articulating arm 24 connecting a monitor 26 to the system 20, a monitor26, an acoustical generator 28, and transducer input port 32. In apreferred embodiment, the system 20 can be rolled on rollers 30 to theoperating room. In another preferred embodiment, the articulating arm 24allows for a complete 360 degree rotation and height adjustment by thesurgeon.

[0047] The transducer 34 is shown in more detail in FIG. 3. Thetransducer 34 includes input and output connections 36 and a probe 38,typically between about 2 and 4 mm in diameter. The transducer emitssignals at a defined bandwidth and frequency which is conveyed to andfrom the input/output connections 36 to the system 20 via the input port32.

[0048] The signals are processed by the CPU 22 to generate signals (FIG.5a) sent to the monitor 26, which then displays an image of the tissuethe probe 38 is passing through. The image 40, shown in FIG. 5b,indicates the cortical interface as a black area 42, and the cancelloustissue as a white area 44. Both radial and sagittal scans can be used toimage the tissue, and to provide measurements in real time of the tissuebeing imaged.

[0049] Two general types of instruments can be used to create the imagesand pilot holes for the surgeon. These consist of instruments such asthe drill bits currently in use, modified to include a transducer, asshown in FIGS. 6a and 6 b, and instruments wherein the transducerincludes a means of creating the pilot hole, as shown in FIGS. 6c and 6d. The latter may be made by modifying existing ultrasound probes toinclude a hard pointed end. FIG. 6a shows a hollow drill bit 50, with aburr 52 for creating the hole, typically 4-5 mm in height and about 2-4mm in diameter, a side scan port 54, a lumen 56, and end for connectionto the input/output means 36. FIG. 6b shows a hollow drill bit 60,through which the transducer 38 can be introduced through the hollowlumen 62, and visualize the area through side port 64 or forward slot66.

[0050]FIG. 6c shows a “joystick” type of instrument 70. The diameter 72is between 4 and 8 mm, typically, with an interior lumen diameter 74 ofbetween 2 and 4 mm. There is a side scan port 76 and forward view port78. A handle 80 directs the drill 82 through the lumen to create thepilot hole in the bone.

[0051]FIG. 6d shows a transducer 84 for use in scanning and drilling apilot hole. The drill bit 86 is about 2-7 mm in diameter. Theinput/output means 88 connects to port 90.

[0052] IOUS can be used to determine the initial starting location thatis optimal for introduction of an implant. For example, the transduceris placed on the lamina and used to detect and characterize the boneinterface where the implant is to be positioned.

[0053] IOUS can be used to navigate through the bone as the surgeonprepares the site for implantation, detecting changes from cortical tocancellous to cartilaginous areas, detecting bone to bone unions, andmore clearly defining the area in which the implant is to be placed. Forexample, IOUS can be used to guide the placement of screws duringguidance of pedicle screws across a vertebral body during spinal fusionor during anterior spinal deformity corrective surgery.

[0054] Further, IOUS can be used as a diagnostic, for measurement ofbone thickness, identification and confirmation of pseudoarthrosis infailed spinal fusions, detection of bone-to-avascular-necrosisinterface, detection of fractures, and search for neoplasms, osteoidosteoma and vascular lesions such as aneurismal bone cysts, etc. Ingeneral the same equipment and analytical techniques will be used as forsurgical placement.

I claim:
 1. A method for guiding and placing an implant within a regionof tissues characterized by defined differences in acoustical impedencecomprising introducing into the region a transducer and receiver forultrasound or audio signals and monitoring differences in acousticalimpedence as the transducer and receiver are moved through the region.2. The method of claim 1 wherein the region is bone and the tissues arecortical bone and cancellous bone.
 3. The method of claim 1 wherein theregion is a joint and the tissues are soft tissues such as ligaments,tendons or cartilage and bone.
 4. The method of claim 1 wherein themethod further comprises locating an implant in the region.
 5. Themethod of claim 4 wherein the implant is a metal, ceramic, biological orpolymeric implant.
 6. The method of claim 5 wherein the implant is screwor pin.
 7. The method of claim 6 wherein the implant is placed into thespinal pedicles.
 8. The method of claim 1 wherein the method is used toguide the placement of pedicle screws across a vertebral body duringanterior spinal deformity corrective surgery.
 9. The method of claim 1wherein the ultrasound is used to measure or provide analysis of one ormore factors or variables selected from the group consisting of Bonemineral density (BMD), Histology of bone, disease, water content,cartilage composition, lesions, vascular defects, neoplasms, and areasof avascular necrosis.
 10. The method of claim 1 wherein the method isused to determine areas of bony non-union, fracture, or regions betweenbone.
 11. A bone drill bit comprising a transducer and receiver.
 12. Thebone drill bit of claim 11 further comprising a means for producing asignal when the drill bit encounters regions having different acousticimpedence.
 13. A system for use in guiding and placing an implant withina region of tissues characterized by defined differences in acousticalimpedence comprising a transducer and receiver for ultrasound or audiosignals and means for monitoring differences in acoustical impedence asthe transducer and receiver are moved through the region.
 14. The systemof claim 13 wherein the region is bone and the tissues are cortical boneand cancellous bone, and the system produces a signal when differencesin density between the cortical bone and the cancellous bone aredetected.
 15. The system of claim 13 wherein the device further includesmeans for cutting tissue or bone.
 16. The system of claim 13 furthercomprising a sensor that detects changes in acoustical impedence. 17.The system claim 16 wherein the sensor produces a detectable signal whenthere is a change in acoustical impedence.
 18. A method of measuringbone characteristics in a region comprising introducing into the regiona transducer and receiver for ultrasound or audio signals and monitoringdifferences in acoustical impedence as the transducer and receiver aremoved through the region.
 19. The method of claim 18 wherein the bonecharacteristic is thickness.
 20. The method of claim 18 wherein the bonecharacteristic is identification and confirmation of pseudoarthrosis infailed spinal fusions.
 21. The method of claim 18 wherein the bonecharacteristics is bone-to-avascular-necrosis interface.
 22. The methodof claim 18 wherein the bone characteristic is an osteoid osteoma orvascular lesion.
 23. The method of claim 22 wherein the vascular lesionis a aneurismal bone cyst.